Abstract
A clinical trial, according to the WHO, “is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc”.
 The application of innovative information technologies like artificial intelligence and big data analytics in clinical trial processes is a new challenge. Such systems are useful tools, and promise to enhance the healthcare management, and to optimize clinical outcomes and economic effectiveness. However, their use raises ethical and social issues.
 In this direction, the European Commission in June 2018 set up the High Level Expert Group on AI, which offers guidance on a comprehensive framework for trustworthy AI. Trustworthy AI consists of three components, which should be met during the entire life cycle of the system: (1) it should be lawful, (2) it should be ethical, and (3) it should be robust.
 In this article we used the focus group methodology to obtain information from experts about the ethical aspects raised when innovative information technologies like artificial intelligence and big data analytics are used in clinical trials. Feedback from the experts was also gathered regarding the usage of the proposed guidelines for trustworthy AI, as an evaluation tool for the particular case of clinical trials.
Highlights
Clinical trials (CTs) are significant for the development of new methods in human treatment
According to the WHO (WHO, 2020) “a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes
The aim of this paper is to demonstrate the ethical aspects that rise by the application of innovative information technology in CTs
Summary
Clinical trials (CTs) are significant for the development of new methods in human treatment. The clinical trial phases of the drug development cycle consume around half of this time and investment (Harrer et al, 2019). Meaning most of these extra costs are due to clinical trials. This is the reason to seek and introduce innovative technologies in clinical trials. Innovative information technologies are widely used in medicine, implementing different systems including mobile telemedicine information systems for patients, medical doctors and other participants in the healthcare ecosystem (Patias & Georgiev, 2017). Concrete innovative information technologies used in CTs include technologies such as artificial intelligence, big data analytics, blockchain, Internet of Things, virtual and augmented reality, simulations or gamification
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